Alvotech Bullish As Facility Deficiencies Hold Up Humira Biosimilar Again
AVT02 Higher-Concentration Adalimumab Formulation Previously Delayed
Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.
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FDA approval for Alvotech and Teva’s AVT02 adalimumab biosimilar has once again failed to materialize as the agency issued another CRL over the product. The setback means the firms will miss their projected launch date of 1 July and will not be part of the pack launching multiple Humira rivals in the coming weeks.
Six months after replacing its chief quality officer, biosimilars specialist Alvotech has again appointed a new head of quality, in the wake of the latest US FDA knockback for its AVT02 proposed adalimumab biosimilar rival to Humira.
Alvotech has received a further complete response letter from the US FDA relating to its AVT02 proposed adalimumab biosimilar rival to Humira. The latest BsUFA goal date disclosed for the product is now just a few days ahead of a potential US launch.